The FDA’s emphasis on laboratory audits in recent years has focused on companies confirming that laboratory data is not fraudulent. With the rise in evidence that justifies the FDA’s fraudulent data concerns — especially internationally — the failure of companies to provide established historical information and ensure compliance on the validation of their analytical methods and procedures increases the risk of receiving an FDA warning letter. 

To reduce a company’s risk and to handle a successful FDA laboratory audit, it is important to start by ensuring that historical laboratory information is up-to-date regarding analytical methods validation, equipment qualification, and personnel qualifications. Any automated equipment should have software controls such as audit trails to assure data integrity. An established calibration program, a written stability program, and laboratory procedures should be in place, up to date, and appropriate to the particular laboratory setting. This includes information from contract testing laboratories, which must also ensure that the methods used in the facilities and the controls used for manufacturing, processing, packing, or holding are operated or administered in conformity with Current Good Manufacturing Practice (CGMP).

This Cleanroom Tip was contributed by Richard Aleman of Pharmatech Associates, who authored “Avoid an FDA Warning Letter in the Laboratory Environment” in the September/October 2016 issue of Controlled Environments.